AMIStem H Femoral Stems 01.18.141Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630030804175), received between Dec 15, 2017 and Jun 25, 2024 — classified as 13 injuries.

The most frequently reported specific device problem is “Osseointegration Problem” (3 reports).

1 other recall cover devices cleared under the same FDA submission (K093944, K250450); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2024Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AND 9 MONTHS AFTER PRIMARY, THE PATIENT HAS BEEN REVISED BECAUSE OF ASEPTIC LOOSENING OF THE STEM. THE SURGERY HAS BEEN COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19606725 ↗
• InjuryNov 8, 2023Osseointegration Problem; Osseointegration Problem

  AT ABOUT 7 YEARS AND 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE MEDACTA HEAD AND STEM WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18092792 ↗
• InjuryOct 14, 2022Osseointegration Problem; Osseointegration Problem

  AT ABOUT 10 YEARS AFTER THE PRIMARY, REVISION OF THE HIP STEM PERFORMED FOLLOWING THE ASEPTICAL LOOSENING OF THE STEM.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15604261 ↗
• InjuryJul 21, 2022Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION AFTER 9 YEARS AND 2 MONTHS FROM THE PRIMARY SURGERY.

  Patient problems: Insufficient Information

  MAUDE report 15075386 ↗
• InjuryDec 23, 2021Loosening of Implant Not Related to Bone-Ingrowth

  AT 8 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED. THE PATIENT HAD A FALL AROUND 2016 AND NOBODY NOTICED THAT PROBABLY HAD A FRACTURE IN THE FEMUR, WHICH MAY HAVE CAUSED THE SUBSIDENCE OF THE STEM.

  Patient problems: Bone Fracture(s)

  MAUDE report 13074877 ↗
• InjuryNov 15, 2019Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 6 YEARS AND 4 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. STEM AND HEAD REPLACED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 9326061 ↗
• InjuryAug 14, 2019Fracture; Appropriate Device Problem Term/Code Not Available

  REASON FOR REVISION WAS DUE TO SECONDARY FRACTURE BELOW STEM. SECONDARY FRACTURE OCCURRED 4 MONTHS AND A HALF AFTER PRIMARY (3 MONTHS AND 1 WEEK AFTER FIRST FRACTURE) THUS WE WERE ALERTED ON (B)(6) 2019 THAT THE REVISION OF STEM AND FEMORAL HEAD WOULD BE PERFORMED ON (B)(6) 2019.

  Patient problems: Bone Fracture(s)

  MAUDE report 8893109 ↗
• InjuryJul 11, 2019Malposition of Device; Appropriate Device Problem Term/Code Not Available

  IMMEDIATE POST-OP SURGERY X-RAYS (THE SAME DAY AS PRIMARY SURGERY) REVEALED THAT THE STEM PERFORATED THE FEMUR AND PLACED WITH A FALSE ROOT. REVISION SURGERY PERFORMED THE SAME DAY THROUGH AMIS APPROACH PERFORMED SUCCESSFULLY REPOSITIONING AND REPLACING THE STEM.

  Patient problems: Hip Fracture

  MAUDE report 8780214 ↗
• InjuryApr 24, 2019Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY AFTER 2 YEARS AND 1 MONTH FROM THE PRIMARY DUE TO PAIN AND INSTABILITY (RADIOLUCENCIES OF AN AMISTEM HA COATED 1 LATERALIZED CEMENTLESS WERE DETECTED). REVISION SURGERY PERFORMED IMPLANTING A QUADRA-C STEM 1 LATERALIZED + PLUG 1.

  Patient problems: Joint Disorder

  MAUDE report 8544517 ↗
• InjuryJan 9, 2019Loose or Intermittent Connection

  ABOUT 6 YEARS AND 8 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT HIP FOR STEM LOOSENING. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 8230877 ↗
• InjuryJun 13, 2018Insufficient Device Problem Information

  ABOUT 4 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT RIGHT HIP FOR OSTEOLYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Osteolysis

  MAUDE report 7596015 ↗
• InjuryFeb 21, 2018Device Slipped; Malposition of Device

  ABOUT 6 YEARS AFTER PRIMARY THE SURGEON REVISED THE PATIENT DUE TO STEM LOOSENING AND MALPOSITIONED CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 7285375 ↗
• InjuryDec 15, 2017Adverse Event Without Identified Device or Use Problem

  ONE YEAR AND 9 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR HIP PAIN. HEAD AND STEM SWAPPED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 7121383 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093944, K250450. One submission often covers many models, so check the product and lot details in each record.

• Z-0791-2013 · Dec 17, 2012 · Terminated
  Medacta Quadra Trial Broach size 0 part # 01.10.10.045, for use with the Medacta Total Hip Prosthesis System. Product Usage - used to broach the intramedullary canal of the femur